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Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
bleomycin sulfate
rituximab
prednisolone
vincristine sulfate
Sponsored by
Lymphoma Trials Office
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring AIDS-related peripheral/systemic lymphoma, AIDS-related diffuse large cell lymphoma, AIDS-related immunoblastic large cell lymphoma, AIDS-related small noncleaved cell lymphoma, AIDS-related diffuse mixed cell lymphoma, AIDS-related diffuse small cleaved cell lymphoma, AIDS-related lymphoblastic lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of poor-prognosis, HIV-related non-Hodgkin's lymphoma (HIV-NHL) Previously untreated More than 1 of the following criteria: Prior diagnosis of AIDS ECOG performance status 3-4 CD4 count less than 100/mm3 No primary cerebral lymphoma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: See Disease Characteristics Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for HIV-NHL At least 1 year since prior chemotherapy for Kaposi's sarcoma (KS) Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy for HIV-NHL allowed At least 1 year since prior radiotherapy for KS Surgery: Not specified

Sites / Locations

  • St. George's Hospital
  • Chelsea Westminster Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 8, 2002
Last Updated
September 19, 2013
Sponsor
Lymphoma Trials Office
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1. Study Identification

Unique Protocol Identification Number
NCT00031902
Brief Title
Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
Official Title
Rituxumab Combined With Chemotherapy (PVB) For Poor Prognosis HIV-Related Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2003
Overall Recruitment Status
Unknown status
Study Start Date
October 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Lymphoma Trials Office

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab with chemotherapy may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of rituximab plus combination chemotherapy in treating patients who have HIV-related non-Hodgkin's lymphoma.
Detailed Description
OBJECTIVES: Determine the response rate of patients with poor-prognosis, HIV-related non-Hodgkin's lymphoma treated with rituximab combined with prednisolone, vincristine, and bleomycin. Determine the toxicity of this regimen in these patients. Determine the time to progression and survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive chemotherapy comprising vincristine IV and bleomycin IV on day 1 and oral prednisolone every other day beginning on day 1. Treatment repeats every 3 weeks for 6 courses. Patients also receive rituximab on days 14, 21, 28, and 35. Patients who achieve complete response (CR) receive 2 additional courses of chemotherapy after CR. Patients are followed every 1-2 months. PROJECTED ACCRUAL: A total of 10-20 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
AIDS-related peripheral/systemic lymphoma, AIDS-related diffuse large cell lymphoma, AIDS-related immunoblastic large cell lymphoma, AIDS-related small noncleaved cell lymphoma, AIDS-related diffuse mixed cell lymphoma, AIDS-related diffuse small cleaved cell lymphoma, AIDS-related lymphoblastic lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
bleomycin sulfate
Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Type
Drug
Intervention Name(s)
prednisolone
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of poor-prognosis, HIV-related non-Hodgkin's lymphoma (HIV-NHL) Previously untreated More than 1 of the following criteria: Prior diagnosis of AIDS ECOG performance status 3-4 CD4 count less than 100/mm3 No primary cerebral lymphoma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: See Disease Characteristics Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for HIV-NHL At least 1 year since prior chemotherapy for Kaposi's sarcoma (KS) Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy for HIV-NHL allowed At least 1 year since prior radiotherapy for KS Surgery: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth Pettengell, MD
Organizational Affiliation
St. George's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
St. George's Hospital
City
London
State/Province
England
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Chelsea Westminster Hospital
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma

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